{"id":1052065,"url":"https://alion.io/job/orca-bio-associate-packaging-operations-and-cold-chain-handling-night-shift","title":"Associate, Packaging Operations and Cold Chain Handling - Night Shift","company":{"id":4299,"name":"Orca Bio","domain":"orcabio.com","url":"https://alion.io/company/orca-bio","size_band":"501-1000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Lever","truth_index":{"grade":"B","score":84,"open_postings":33,"ghost_share":0.182,"stale_share":0,"repost_share":0,"time_to_fill_p50_days":78,"computed_at":"2026-11-12T10:38:37Z"}},"role":"Field & Service","role_family":"Field & Service","seniority":"junior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Sacramento, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":65465,"max":71571,"currency":"USD","period":"year","gross":null,"usd_annual":71571},"salary_estimate":null,"experience_years_min":1,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"GMP","optional":false}],"status":"live","first_seen_at":"2026-03-06T18:51:06Z","employer_posted_date":"2026-03-06","last_verified_at":"2026-11-12T17:25:52Z","board_verified":true,"closed_at":null,"days_open":251,"trust":{"level":"ghost","repost_count":0,"flags":["stale","company_stale"],"days_open":250},"description":"The Associate, Packaging Operations and Cold Chain Handling - Night Shift supports critical operations related to the receipt of patient materials (leukapheresis/blood), cryopreservation of cellular products, and preparation and coordination of final drug product shipments. This role will operate with a deep understanding of GMP manufacturing, cell therapy processes, and the ability to execute multiple tasks in a fast-paced environment.\nNight Shift Hours Worked:\n6:00pm to 6:30am or\n6:30pm to 7:00am\nWork Week Schedule:\nSunday, Monday, Tuesday + every other Wednesday or\nThursday, Friday, Saturday + every other Wednesday\nPhysical Demands & Work Conditions\nProduction Associates: Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks such as visual inspection of materials, equipment, and labeling, including distinguishing color-coded components in a GMP environment.\nMust meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for up to 3 consecutive hours at a time, minimal movement in the cleanroom, and working with or around human blood, blood-derived materials, cells, other biological materials, and alcohol-based sprays. Use of cosmetics (makeup, painted nails), jewelry, or facial piercings is not permitted in the cleanroom, and any skin conditions that cause shedding must be disclosed.\nMust be comfortable regularly participating in video-based meetings.\nPhysical Demands\nProduction Associate Roles: Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks such as visual inspection of materials, equipment, and labeling, including distinguishing color-coded components in a GMP environment.\nMust be able to meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for extended periods, as needed. Use of cosmetics (makeup, painted nails), jewelry, or facial piercings is not permitted in the cleanroom, and any skin conditions that cause shedding must be disclosed.\nWork Conditions\nMust be able to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs.\nMust be comfortable regularly participating in video-based meetings.\nMay be required to work scheduled overtime, weekends, or holidays based on business needs.\nEssential Duties & Key Responsibilities\nBlood Intake & Chain-of-Identity Management:\nReceive and verify incoming apheresis materials according to SOPs and regulatory requirements. \nPerform visual inspections and documentation checks to ensure proper labeling, temperature, and packaging. \n Maintain strict adherence to chain-of-identity and chain-of-custody procedures. \n Cryopreservation Support:\nAssist in the preparation and cryopreservation of intermediate and final cellular products. \nOperate and maintain cryogenic storage equipment (e.g., controlled-rate freezers, LN2 tanks). \nAccurately complete batch records and electronic documentation systems. \n Drug Product Shipment:\nCoordinate the labeling, packaging, and final release of drug product for shipment. \nPrepare shipping materials, confirm shipping conditions (e.g., temperature control), and liaise with logistics partners. \nEnsure real-time data entry into inventory, tracking systems and eBRs \n Perform other duties as assigned\nWork closely with Quality Assurance, Supply Chain, and Manufacturing teams to ensure timely and compliant operations. \nSupport deviation investigations, CAPAs, and continuous improvement initiatives as needed. \nMaintain accurate and complete records in accordance with GMP and GDP standards. \nGood Manufacturing Practices (GMP) Training \nMinimum Qualifications\nBachelor’s degree in Life Sciences, Engineering, or related field preferred. \n1-3 years of experience in a GMP-regulated biotech or pharmaceutical environment preferred. \nStrong understanding of cell therapy manufacturing processes \nStrong attention to detail, organizational skills and document accuracy. \nAbility to work with biological materials and cryogenic systems \nKnowledge of regulatory compliance (FDA and GxP) a plus \nComfortable working in a clean room and or cold environment (Liquid Nitrogen storage) \nTravel Requirements and Work Environment\nDomestic and international travel not required \nMay involve standing for extended periods and lifting up to 25 lbs \nShift work, weekends, or holidays may be required depending on production needs \nExposure to human blood products and temperature-controlled storage areas \nGowning and use of Personal Protective Equipment required","description_format":"text","description_chars":4663,"description_truncated":false,"requirements":{"experience_years_min":1,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Supply Chain","Cell & Gene Therapy","Oncology Therapeutics"],"lifecycle":[{"event":"open","at":"2026-09-19T00:26:33Z"}],"visa":[],"liveness":{"score":8,"band":"cold","label":"Long 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